FDA letter monthly archive

FDA Letters in February 2021

Name: FDA Letters in February 2021
Creator: Assyro AI
License: https://www.usa.gov/government-works

Browse FDA application-action, complete response, and warning letters issued or posted in February 2021. Each result links to a structured letter page with source-document access, metadata, and regulatory intelligence summaries.

CRLComplete Response Letter
Complete Response Letter CorMedix Inc. (Feb 26, 2021)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedFeb 26, 2021
US FDA• DEFENCATH
CRLComplete Response Letter
Complete Response Letter CMP Development LLC (Feb 23, 2021)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedFeb 23, 2021
US FDA• TADLIQ
CRLComplete Response Letter
Complete Response Letter Novitium Pharma LLC (Feb 12, 2021)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Bioequivalence and pharmacokinetics, Chemistry, manufacturing, and controls. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedFeb 12, 2021
US FDA• SOVUNA

Complete Response Letter CorMedix Inc. (Feb 26, 2021)

Complete Response Letter CMP Development LLC (Feb 23, 2021)

Complete Response Letter Novitium Pharma LLC (Feb 12, 2021)